8-K
Theriva Biologics, Inc. (TOVX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest eventreported): January 9, 2023
THERIVA BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 001-12584 | 13-3808303 |
|---|---|---|
| (State or other jurisdiction of<br><br> <br>incorporation) | (Commission File No.) | (IRS Employer Identification<br><br> <br>No.) |
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
(301) 417-4364
Registrant’s telephone number, including area code
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, par value $0.001 per share | TOVX | NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation FD Disclosure.
On January 9, 2023, Theriva Biologics, Inc. (the “Company”) issued a press release announcing that the first patient has been dosed in the Company’s Phase 1 investigator sponsored clinical trial of VCN-01, an intravenous oncolytic adenovirus, for patients with high-grade brain tumors who are scheduled for surgical resection.
The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. OtherEvents.
On January 9, 2023, the Company issued a press release announcing that the first patient has been dosed in the Company’s Phase 1 investigator sponsored clinical trial of VCN-01, an intravenous oncolytic adenovirus, for patients with high-grade brain tumors who are scheduled for surgical resection.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
|---|---|
| ExhibitNumber | Description |
| --- | --- |
| 99.1 | Press Release issued by Theriva Biologics, Inc., dated January 9, 2023 |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: January 9, 2023 | THERIVA BIOLOGICS, INC. | ||
|---|---|---|---|
| By: | /s/ Steven A. Shallcross | ||
| Name: | Steven A. Shallcross | ||
| Title: | Chief Executive Officer and Chief Financial Officer |
Exhibit 99.1
Theriva Biologics Announces Dosing of FirstPatient in the Investigator Sponsored Phase 1 Trial of VCN-01, an Intravenous Oncolytic Adenovirus, in Patients with Brain Tumors
-Clinical trial is being conducted at St. James’sUniversity Hospital, United Kingdom, in collaboration with the University of Leeds-
Rockville, MD, January 9, 2023 – Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the first patient has been dosed in the Phase 1 investigator sponsored clinical trial of VCN-01, an intravenous oncolytic adenovirus, for patients with high-grade brain tumors who are scheduled for surgical resection.
“We are pleased to dose the first patient and evaluate the ability of our lead oncolytic adenovirus, VCN-01, to enter brain tumors following systemic administration,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “This design builds on the data that we obtained from previous trials of systemically delivered VCN-01 for treating metastatic pancreatic cancer, another difficult to treat disease. If the results show that VCN-01 gains entry to brain tumors that are otherwise only accessible through surgery, this could be transformative for patients by enabling multiple treatments with VCN-01 without the complications of brain surgery. We look forward to driving this program forward and addressing the unmet need for the thousands of patients with primary or metastatic brain tumors who could potentially benefit from this novel oncolytic therapy.”
Trial Design:
The Phase 1, open-label, non-randomized trial is designed to evaluate the safety, tolerability and intratumoral presence of VCN-01 administered intravenously at a single dose of 1 x 10^13^ vp (virus particles) in up to 12 patients with recurrent high-grade glioma or brain metastases, prior to planned surgery. All patients will undergo surgical resection of their tumors between eight and 15 days following VCN-01 infusion, allowing for assessment of any toxicities and their resolution. More information about the trial is available here.
The clinical trial is being led by Dr. Adel Samson, an expert in clinical immunotherapy and Head of the Translational Cancer Immunotherapy Group at the University of Leeds, as well as Professor Susan Short of Clinical Oncology and Neuro-oncology and Head of the Brain Cancer Research Section at Leeds Institute of Cancer and Pathology. The trial is funded by The Brain Tumour Charity and Cancer Research UK.
Dr. Samson commented, “Patients with recurrent high-grade primary brain tumors typically have a poor prognosis, and often have to undergo one or more surgical interventions to remove their tumors. The leaky vasculature of many brain tumors may provide an excellent opportunity for systemically administered VCN-01 to enter the tumor, where it can replicate and initiate tumor cell killing, immune stimulation and destruction of tumor stroma. This could provide a more effective and less invasive therapeutic option for these patients.”
About Theriva Biologics, Inc.
Theriva Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statementswithin the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identifiedby terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions,and include statements regarding VCN-01 being transformative for patients by enabling multiple treatments with VCN-01, driving the VCN-01program forward and addressing the unmet need for the thousands of patients with primary or metastatic brain tumors who could potentiallybenefit from this novel oncolytic therapy, the leaky vasculature of many brain tumors providing an excellent opportunity for systemicallyadministered VCN-01 to enter the tumor, where it can replicate and initiate tumor cell killing, immune stimulation and destruction oftumor stroma and VCN-01 providing a more effective and less invasive therapeutic option for patients with primary or metastatic braintumors. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press releaseand are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differmaterially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factorsthat could cause actual results to differ materially from current expectations include, among others, the ability of VCN-01 to treat multiple indications, the ability of VCN-01 to address the unmet need for the thousands of patients with primary or metastatic brain tumors and provide a more effective and less invasive therapeutic option for patients with primary or metastatic brain tumors, the Company’sand VCN’s ability to reach clinical milestones when anticipated, the Company’s ability to successfully combine and operatethe business of the Theriva Biologics and VCN, the Company’s and VCN’s product candidates demonstrating safety and effectiveness,as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired resultsand benefits, continuing clinical trial enrollment as expected; the ability to obtain regulatory approval for commercialization of productcandidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and VCN’s abilityto promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplaceand the successful development, marketing or sale of the Company’s and VCN’s products, developments by competitors that rendersuch products obsolete or non-competitive, the Company’s and VCN’s ability to maintain license agreements, the continued maintenanceand growth of the Company’s and VCN’s patent estate, the ability to continue to remain well financed and other factors describedin the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 and its other filings with the SEC, including subsequentperiodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of thisrelease, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on accountof new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
917-680-5608